Senior PSMF Associate Lisboa

Senior PSMF Associate
Lisboa
Lisboa, Lisboa, Portugal

Company Description

We are Prime
Vigilance (part of Ergomed Group), a specialised
- size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia, covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

Prime
Vigilance provides
- class support to our small to large pharmaceutical and biotechnology partners, maintaining
- lasting relationships, and has become one of the global leaders in its field. We cover all therapy areas, including medical devices.

We invest in our staff by providing excellent training and development opportunities. We value employee experience,
- being, and mental health, and recognize that a healthy
- life balance is crucial for employee satisfaction and delivering
- quality client service.

Join us on this exciting journey to make a positive impact on patients’ lives.

Job Description

This position is primarily responsible for creating, maintaining, and reviewing client Pharmacovigilance System Master Files (PSMF), in accordance with global regulations, legislation, Prime
Vigilance, and client requirements.

Key responsibilities include:

• Authoring, revising, and quality checking PSMFs
• Tracking PSMF activities
• Participating in regular PSMF meetings with internal teams and clients
• Supporting audits related to PSMF activities
• Completing tasks assigned by the Line Manager
• Senior colleagues may perform additional tasks as per SOPs

Qualifications

• Degree qualification preferred, ideally in life sciences such as pharmacy, nursing, or other healthcare fields
• Some experience or knowledge of Pharmacovigilance required
• Strong organizational skills, attention to detail, and ability to multitask
• Effective management skills, including time and issue management
• Excellent communication skills
• Advanced proficiency in English (spoken and written)

Additional Information

Why Prime
Vigilance?

We prioritize diversity, equity, and inclusion by fostering an equal opportunities workplace and a
- centric environment where people of all backgrounds can contribute and grow.

We believe in working together with a
- first approach because our people are our greatest strength, driving our success in improving lives.

We offer:

• Internal training and career development opportunities
• Focus on personal and professional growth
• A friendly, supportive work environment
• Opportunities to collaborate with colleagues worldwide, with English as the company language

Our core values are central to our operations:

• Quality
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging
• Collaborative Partnerships

Join us in this exciting journey to positively impact patients’ lives. We look forward to receiving your application.